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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K133333
FOIA Releasable 510(k) K133333
Device Name UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
Applicant
Blue Ocean Medical Product, LLC
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Blue Ocean Medical Product, LLC
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/29/2013
Decision Date 12/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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